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Objectives: This study aims to ascertain the cost-effectiveness of magnetic resonance-guided focused ultrasound (MRgFUS) for the treatment of medically refractory Essential Tremor (mrET) in England. Essential Tremor (ET) is the most common movement disorder affecting approximately 1 million in the UK causing considerable societal impact affecting patients, carers and the wider healthservice. Medical treatment has mixed efficacy, with approximately 25–55% of ET medication refractory. Deep brain stimulation (DBS) is a proven neurosurgical treatment; however, the risks of surgery and anaesthesia mean some patients are ineligible. MRgFUS is an emerging noninvasive technique that causes tremor suppression by thermal ablation of tremor-sensitive brain tissue. Several international clinical trials have demonstrated MRgFUS is safe and clinically effective; however, to-date no cost-effectiveness study has been performed in Europe. Methods: A Markov model was used to assess two subpopulations of mrET – those eligible and those ineligible for neurosurgery – in the context specific to England and its healthcare system. For those eligible for neurosurgery, MRgFUS was compared to DBS, the current standard treatment. For those ineligible for neurosurgery, MRgFUS was compared to treatment with medication alone. The model calculated the Incremental cost-effectiveness ratio (ICER) with appropriate sensitivity and scenario analyses. Results: For those eligible for neurosurgery: In the model base case, the MRgFUS was economically dominant compared to DBS; MRgFUS was less costly (£19,779 vs £62,348) and more effective generating 0.03 additional quality-adjusted life-years (QALYs) per patient (3.71 vs 3.68) over the 5-year time horizon. For those ineligible for neurosurgery: In the model base case, MRgFUS cost over £16,000 per patient more than medication alone (£19,779 vs £62,348) but yielded 0.77 additional QALYs per patient(3.71 vs 2.95), producing an incremental cost-effectiveness ratio (ICER) of £20,851 per QALY. This ICER of £20,851 per QALY falls within the National Institute for Clinical Excellence’s (NICE) willingness to pay threshold (WTP) of 20,000–30,000 demonstrating the cost-effectiveness profile of MRgFUS. Conclusion: This study demonstrates the favourable cost-effectiveness profile of MRgFUS for the treatment of mrET in England; in both patients suitable and not suitable for neurosurgery. Advances in knowledge: The introduction of MRgFUS as a widely available ET treatment in UK is currently undergoing the necessary stages of regulatory approval. As the first European study, these favourable cost-effectiveness outcomes (notably the model base case ICER falling within NICE’s WTP) can provide a basis for future commissioning of brain MRgFUS treatments in the UK, Europe and globally.

ObjectiveTo compare the cost and effects of three sampling strategies for human papillomavirus (HPV) primary screening.DesignCost-consequence analysis using a decision tree in Excel.SettingEngland.ParticipantsA cohort of 10,000 women age 25 to 65 eligible for the NHS Cervical Screening Programme (NHSCSP) (Box 1).MethodsThe model was informed by the NHSCSP HPV primary screening pathway and adapted for self-sampling. It used a 3-year recall cycle with routine screening in year 1 and recall screening in years 2/3. Parameters were obtained from published studies, manufacturers, NHSCSP reports, and input from experts.InterventionsThree sampling strategies were: 1) routine clinician-collected cervical sample, 2) self-collected first-void (FV) urine; 3) self-collected vaginal swab. The hypothetical self-sampling strategies involved women being mailed a sampling kit at home.Main outcome measuresPrimary outcomes: overall costs (for all screening steps to colposcopy), number of complete screens, and cost per complete screen. Secondary outcomes: number of women screened, number of women lost to follow-up, cost per colposcopy, and total screening costs for a plausible range of uptake scenarios.ResultsIn the base case, the average cost per complete screen was £56.81 for clinician-collected cervical sampling, £38.57 for FV urine self-sampling, and £40.37 for vaginal self-sampling. In deterministic sensitivity analysis (DSA), the variables most affecting the average cost per screen were the cost of sample collection for clinician-collected sampling and the cost of laboratory HPV testing for the self-sampling strategies. Scaled to consider routine screening in England, if uptake in non-attenders increased by 15% and 50% of current screeners converted to self-sampling, the NHSCSP would save £19.2 million (FV urine) or £16.5 million (vaginal) per year.ConclusionSelf-sampling could provide a less costly alternative to clinician-collected sampling for routine HPV primary screening and offers opportunities to expand the reach of cervical screening to under-screened women.Strengths and limitations of the studyThis is the first study to assess the cost of screening for cervical cancer using self-collected first-void urine or vaginal swab compared to the current strategy of clinician-collected cervical sampling within the context of England’s NHS Cervical Screening Programme (NHSCSP).The cost per screen was used to calculate the total cost of the NHSSCP in England, allowing a comparison of different uptake scenarios if self-sampling was offered to non-attenders only or to all eligible women.Limited published data were available to inform the cost of self-sampling devices and HPV laboratory testing of self-collected samples.One pathway for self-sampling was examined. However, there are alternative pathways which could be explored, some of which are dependent on new technologies, such as DNA methylation testing, being validated and costed.

Anne Meiwald,1 Rupert Gara-Adams,1 Aleix Rowlandson,1 Yixuan Ma,1 Henrik Watz,2 Masakazu Ichinose,3 Jane Scullion,4 Tom Wilkinson,5,6 Mohit Bhutani,7 Georgie Weston,1 Elisabeth J Adams1 1Aquarius Population Health, London, UK; 2Pulmonary Research Institute, LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Schleswig-Holstein, Germany; 3Academic Center, Osaki Citizen Hospital, Miyagi, Japan; 4Bush & Co, Northamptonshire, UK; 5Faculty of Medicine, Southampton University, Southampton, Hampshire, UK; 6Respiratory and Allergy, NIHR Southampton Biomedical Research Centre, Southampton, Hampshire, UK; 7Department of Medicine, University of Alberta, Edmonton, Alberta, CanadaCorrespondence: Elisabeth J Adams, Aquarius Population Health, Unit 29 Tileyard Studios, London, N7 9AH, UK, Tel +44 (0)207 993 2930, Email elisabeth.adams@aquariusph.comBackground: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. A comprehensive and detailed understanding of COPD care pathways from pre-diagnosis to acute care is required to understand the common barriers to optimal COPD care across diverse health systems.Methods: Country-specific COPD care pathways were created for four high-income countries using international recommendations and country-specific guidelines, then populated with published epidemiological, clinical, and economic data. To refine and validate the pathways, semi-structured interviews using pre-prepared discussion guides and country-specific pathway maps were held with twenty-four primary and secondary care respiratory healthcare professionals. Thematic analysis was then performed on the interview transcripts.Results: The COPD care pathway showed broad consistency across the countries. Three key themes relating to barriers in optimal COPD management were identified across the countries: journey to diagnosis, treatment, and the impact of COVID-19. Common barriers included presentation to healthcare with advanced COPD, low COPD consideration, and sub-optimal acute and chronic disease management. COVID-19 has negatively impacted disease management across the pathway but presents opportunities to retain virtual consultations. Structural factors such as insurance and short duration of appointments also impacted the diagnosis and management of COPD.Conclusion: COPD is an important public health issue that needs urgent prioritization. The use of Evidenced Care Pathways with decision-makers can facilitate evidence-based decision making on interventions and policies to improve care and outcomes for patients and reduce unnecessary resource use and associated costs for the healthcare provider/payer.Keywords: health policy, COPD management, COPD diagnosis, exacerbations, qualitative, pathway mapping

Highlights • Using an mRNA HPV test in cervical screening can reduce costs and avoid procedures. • This could benefit both the healthcare system and women by optimizing resource use. • These results can inform choices in cervical screening programs in Canada., This study models the impact of using two different types of high-risk (HR) human papillomavirus (HPV) tests: mRNA (Aptima) and DNA (Hybrid Capture 2) as part of a hypothetical primary HPV screening program in Ontario, Canada. Outcomes were the costs of the screening program, and number of colposcopies, HPV tests and cytology tests. Results were estimated for one cohort going through the screening algorithm. A decision tree model was adapted from a published UK study, with inputs drawn from published Canadian data for the probabilities through the model, costs, demographic, and screening data from Ontario. Sensitivity and scenario analyses explored uncertainty in the model inputs and assumptions. Results indicated that screening using an mRNA test could yield cost savings of CAD $4,007,266 (95% credibility interval [CI]: −7,866,251 – 8,035) compared to using a DNA test, with 10,639 (95% CI: 10,170 – 11,094) fewer women undergoing unnecessary colposcopies, and reductions in unnecessary HR-HPV and cytology tests. The HR-HPV test comprised the largest percentage of the costs saved, and the probability of being HPV positive in the first year had the biggest impact on results. These results indicate that the choice of HR-HPV test is important when implementing a primary HPV screening program to avoid unnecessary resource use and cost, which will benefit both women and healthcare providers.

Population screening programmes must make good use of resources for the health system and users. To evaluate impacts of the type of diagnostic test in the new French cervical screening programme, an messenger ribonucleic acid (mRNA) high-risk human papillomavirus assay was compared to a deoxyribonucleic acid (DNA) high-risk human papillomavirus assay for a hypothetical cohort of women aged 25 to 65 years.This evaluation takes the perspective of the French healthcare system.France.A decision tree model reflecting the French cervical screening algorithms was parametrised using French cost and population data and the Danish Horizon study. The outcomes were total costs, and number of colposcopies, HPV tests and cytology tests for the cohort. One-way and probabilistic sensitivity analyses and scenarios analyses were conducted to test the robustness of results to parameter and structural uncertainty.Adopting an mRNA versus DNA assay as part of national cervical screening in France is estimated to save €6.5 million (95% credibility intervals €-1.3 - €13.5 million) and prevent 47,795 (95% credibility intervals 35,309 - 60,139) unnecessary colposcopies, 38,666 unnecessary HPV tests and 121,670 cytology tests over two years for a cohort of 2,168,806 million women aged 25 to 65 years. Sensitivity analyses indicated robust results across a range of inputs.The choice of high-risk human papillomavirus assay makes a significant difference to resource use and costs and is important to consider when implementing cervical screening in France. Using an mRNA versus DNA assay can result in cost savings and reductions in unnecessary testing and procedures, which in turn benefits women and the health care system.

ObjectivesTo assess the cost-effectiveness of universal repeat screening for syphilis in late pregnancy, compared with the current strategy of single screening in early pregnancy with repeat screening offered only to high-risk women.DesignA decision tree model was developed to assess the incremental costs and health benefits of the two screening strategies. The base case analysis considered short-term costs during the pregnancy and the initial weeks after delivery. Deterministic and probabilistic sensitivity analyses and scenario analyses were conducted to assess the robustness of the results.SettingUK antenatal screening programme.PopulationHypothetical cohort of pregnant women who access antenatal care and receive a syphilis screen in 1 year.Primary and secondary outcome measuresThe primary outcome was the cost to avoid one case of congenital syphilis (CS). Secondary outcomes were the cost to avoid one case of intrauterine fetal demise (IUFD) or neonatal death and the number of women needing to be screened/treated to avoid one case of CS, IUFD or neonatal death. The cost per quality-adjusted life year gained was assessed in scenario analyses.ResultsBase case results indicated that for pregnant women in the UK (n=725 891), the repeat screening strategy would result in 5.5 fewer cases of CS (from 8.8 to 3.3), 0.1 fewer cases of neonatal death and 0.3 fewer cases of IUFD annually compared with the single screening strategy. This equates to an additional £1.8 million per case of CS prevented. When lifetime horizon was considered, the incremental cost-effectiveness ratio for the repeat screening strategy was £120 494.ConclusionsUniversal repeat screening for syphilis in pregnancy is unlikely to be cost-effective in the current UK setting where syphilis prevalence is low. Repeat screening may be cost-effective in countries with a higher syphilis incidence in pregnancy, particularly if the cost per screen is low.

Background Pelvic organ prolapse is a common problem in women. About 40% of women will experience prolapse in their lifetime, with the proportion expected to rise in line with an ageing population. Women experience a variety of troublesome symptoms as a consequence of prolapse, including a feeling of 'something coming down' into the vagina, pain, urinary symptoms, bowel symptoms and sexual difficulties. Treatment for prolapse includes surgery, pelvic floor muscle training (PFMT) and vaginal pessaries. Vaginal pessaries are passive mechanical devices designed to support the vagina and hold the prolapsed organs back in the anatomically correct position. The most commonly used pessaries are made from polyvinyl-chloride, polythene, silicone or latex. Pessaries are frequently used by clinicians with high numbers of clinicians offering a pessary as first-line treatment for prolapse. This is an update of a Cochrane Review first published in 2003 and last published in 2013. Objectives To assess the effects of pessaries (mechanical devices) for managing pelvic organ prolapse in women; and summarise the principal findings of relevant economic evaluations of this intervention. Search methods We searched the Cochrane Incontinence Specialised Register which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 January 2020). We searched the reference lists of relevant articles and contacted the authors of included studies. Selection criteria We included randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in at least one arm of the study. Data collection and analysis Two review authors independently assessed abstracts, extracted data, assessed risk of bias and carried out GRADE assessments with arbitration from a third review author if necessary. Main results We included four studies involving a total of 478 women with various stages of prolapse, all of which took place in high-income countries. In one trial, only six of the 113 recruited women consented to random assignment to an intervention and no data are available for those six women. We could not perform any meta-analysis because each of the trials addressed a different comparison. None of the trials reported data about perceived resolution of prolapse symptoms or about psychological outcome measures. All studies reported data about perceived improvement of prolapse symptoms. Generally, the trials were at high risk of performance bias, due to lack of blinding, and low risk of selection bias. We downgraded the certainty of evidence for imprecision resulting from the low numbers of women participating in the trials. Pessary versus no treatment: at 12 months' follow-up, we are uncertain about the effect of pessaries compared with no treatment on perceived improvement of prolapse symptoms (mean difference (MD) in questionnaire scores -0.03, 95% confidence interval (CI) -0.61 to 0.55; 27 women; 1 study; very low-certainty evidence), and cure or improvement of sexual problems (MD -0.29, 95% CI -1.67 to 1.09; 27 women; 1 study; very low-certainty evidence). In this comparison we did not find any evidence relating to prolapse-specific quality of life or to the number of women experiencing adverse events (abnormal vaginal bleeding or de novo voiding difficulty). Pessary versus pelvic floor muscle training (PFMT): at 12 months' follow-up, we are uncertain if there is a difference between pessaries and PFMT in terms of women's perceived improvement in prolapse symptoms (MD -9.60, 95% CI -22.53 to 3.33; 137 women; low-certainty evidence), prolapse-specific quality of life (MD -3.30, 95% CI -8.70 to 15.30; 1 study; 116 women; low-certainty evidence), or cure or improvement of sexual problems (MD -2.30, 95% -5.20 to 0.60; 1 study; 48 women; low-certainty evidence). Pessaries may result in a large increase in risk of adverse events compared with PFMT (RR 75.25, 95% CI 4.70 to 1205.45; 1 study; 97 women; low-certainty evidence). Adverse events included increased vaginal discharge, and/or increased urinary incontinence and/or erosion or irritation of the vaginal walls. Pessary plus PFMT versus PFMT alone: at 12 months' follow-up, pessary plus PFMT probably leads to more women perceiving improvement in their prolapse symptoms compared with PFMT alone (RR 2.15, 95% CI 1.58 to 2.94; 1 study; 260 women; moderate-certainty evidence). At 12 months' follow-up, pessary plus PFMT probably improves women's prolapse-specific quality of life compared with PFMT alone (median (interquartile range (IQR)) POPIQ score: pessary plus PFMT 0.3 (0 to 22.2); 132 women; PFMT only 8.9 (0 to 64.9); 128 women; P = 0.02; moderate-certainty evidence). Pessary plus PFMT may slightly increase the risk of abnormal vaginal bleeding compared with PFMT alone (RR 2.18, 95% CI 0.69 to 6.91; 1 study; 260 women; low-certainty evidence). The evidence is uncertain if pessary plus PFMT has any effect on the risk of de novo voiding difficulty compared with PFMT alone (RR 1.32, 95% CI 0.54 to 3.19; 1 study; 189 women; low-certainty evidence). Authors' conclusions We are uncertain if pessaries improve pelvic organ prolapse symptoms for women compared with no treatment or PFMT but pessaries in addition to PFMT probably improve women's pelvic organ prolapse symptoms and prolapse-specific quality of life. However, there may be an increased risk of adverse events with pessaries compared to PFMT. Future trials should recruit adequate numbers of women and measure clinically important outcomes such as prolapse specific quality of life and resolution of prolapse symptoms. The review found two relevant economic evaluations. Of these, one assessed the cost-effectiveness of pessary treatment, expectant management and surgical procedures, and the other compared pessary treatment to PFMT.

Background Widespread ceftriaxone antimicrobial resistance (AMR) threatens Neisseria gonorrhoeae (NG) treatment, with few alternatives available. AMR point-of-care tests (AMR POCT) may enable alternative treatments, including abandoned regimens, sparing ceftriaxone use. We assessed cost-effectiveness of five hypothetical AMR POCT strategies: A-C included a second antibiotic alongside ceftriaxone; and D and E consisted of a single antibiotic alternative, compared with standard care (SC: ceftriaxone and azithromycin). Aim Assess costs and effectiveness of AMR POCT strategies that optimise NG treatment and reduce ceftriaxone use. Methods The five AMR POCT treatment strategies were compared using a decision tree model simulating 38,870 NG-diagnosed England sexual health clinic (SHC) attendees; A micro-costing approach, representing cost to the SHC (for 2015/16), was employed. Primary outcomes were: total costs; percentage of patients given optimal treatment (regimens curing NG, without AMR); percentage of patients given non-ceftriaxone optimal treatment; cost-effectiveness (cost per optimal treatment gained). Results All strategies cost more than SC. Strategy B (azithromycin and ciprofloxacin (azithromycin preferred); dual therapy) avoided most suboptimal treatments (n = 48) but cost most to implement (GBP 4,093,844 (EUR 5,474,656)). Strategy D (azithromycin AMR POCT; monotherapy) was most cost-effective for both cost per optimal treatments gained (GBP 414.67 (EUR 554.53)) and per ceftriaxone-sparing treatment (GBP 11.29 (EUR 15.09)) but with treatment failures (n = 34) and suboptimal treatments (n = 706). Conclusions AMR POCT may enable improved antibiotic stewardship, but require net health system investment. A small reduction in test cost would enable monotherapy AMR POCT strategies to be cost-saving.

BackgroundLow uptake of sexually transmitted infection testing by sexually active young people is a worldwide public health problem. Screening in non-medical settings has been suggested as a method to improve uptake. The “Test n Treat” feasibility trial offered free, on-site rapid chlamydia/gonorrhoea tests with same day treatment for chlamydia (and gonorrhoea treatment at a local clinic,) to sexually active students (median age 17 years) at six technical colleges in London. Despite high rates of chlamydia (6% prevalence), uptake of testing was low (MethodsIn 2016–17 we conducted a qualitative study in the interpretative tradition using face to face or telephone semi-structured interviews with students (n = 26), teaching staff (n = 3) and field researchers (n = 4). Interviews were digitally recorded, transcribed and thematically analysed.ResultsFrom the student perspective, feelings of embarrassment and the potential for stigma were deterrents to sexually transmitted infection testing. While the non-medical setting was viewed as mitigating against stigma, for some students volunteering to be screened exposed them to detrimental judgements by their peers. A small financial incentive to be screened was regarded as legitimising volunteering in a non-discrediting way. Staff and researchers confirmed these views. The very low level of knowledge about sexually transmitted infections influenced students to not view themselves as candidates for testing. There were also suggestions that some teenagers considered themselves invulnerable to sexually transmitted infections despite engaging in risky sexual behaviours. Students and researchers reported the strong influence peers had on uptake, or not, of sexually transmitted infection testing.ConclusionsThis study offers new insights into the acceptability of college-based sexually transmitted infection screening to young, multi-ethnic students. Future studies in similar high risk, hard to reach groups should consider linking testing with education about sexually transmitted infections, offering non stigmatising incentives and engaging peer influencers.

Background Community-based screening may be one solution to increase testing and treatment of sexually transmitted infections in sexually active teenagers, but there are few data on the practicalities and cost of running such a service. We estimate the cost of running a ‘Test n Treat’ service providing rapid chlamydia (CT) and gonorrhoea (NG) testing and same day on-site CT treatment in technical colleges. Methods Process data from a 2016/17 cluster randomised feasibility trial were used to estimate total costs and service uptake. Pathway mapping was used to model different uptake scenarios. Participants, from six London colleges, provided self-taken genitourinary samples in the nearest toilet. Included in the study were 509 sexually active students (mean 85/college): median age 17.9 years, 49% male, 50% black ethnicity, with a baseline CT and NG prevalence of 6 and 0.5%, respectively. All participants received information about CT and NG infections at recruitment. When the Test n Treat team visited, participants were texted/emailed invitations to attend for confidential testing. Three colleges were randomly allocated the intervention, to host (non-incentivised) Test n Treat one and four months after baseline. All six colleges hosted follow-up Test n Treat seven months after baseline when students received a £10 incentive (to participate). Results The mean non-incentivised daily uptake per college was 5 students (range 1 to 17), which cost £237 (range £1082 to £88) per student screened, and £4657 (range £21,281 to £1723) per CT infection detected, or £13,970 (range £63,842 to £5169) per NG infection detected. The mean incentivised daily uptake was 19 students which cost £91 per student screened, and £1408/CT infection or £7042/NG infection detected. If daily capacity for screening were achieved (49 students/day), costs including incentives would be £47 per person screened and £925/CT infection or £2774/NG infection detected. Conclusions Delivering non-incentivised Test n Treat in technical colleges is more expensive per person screened than CT and NG screening in clinics. Targeting areas with high infection rates, combined with high, incentivised uptake could make costs comparable. Trial registration ISRCTN58038795, Assigned August 2016, registered prospectively.

Objectives\ud We conducted a cluster-randomized feasibility trial of 90-minute Chlamydia trachomatis tests and same day on-site treatment (‘Test n Treat/TnT’) in six technical colleges in London, England, to assess TnT uptake rates; follow-up rates; prevalence of C. trachomatis at baseline and 7 months; time to treatment; acceptability of TnT.\ud \ud Methods\ud Participants completed questionnaires and provided genitourinary samples at baseline and 7 months. Participants were informed that baseline samples would not be tested for 7 months and were advised to get screened independently. Colleges were randomly allocated 1:1 to intervention (TnT) or control (no TnT).\ud \ud One month and 4 months post recruitment, participants at intervention colleges were texted invitations for on-site free C. trachomatis tests. A purposive sample of students who did/did not attend for screening were interviewed (n = 26).\ud \ud Results\ud Five hundred and nine sexually active students were recruited: median age 17.9 years, 47% male, 50% black ethnicity, 55% reporting two or more sexual partners in the previous year. TnT uptake was 13% (33/259; 95% CI 8.9–17.4%) at 1 month and 10% (26/259; 6.7–14.4%) at 4 months with overall C. trachomatis positivity 5.1% (3/59; 1.1–14.2%). Follow-up at 7 months was 62% (317/509) for questionnaires and 52% (264/509) for samples. C. trachomatis prevalence was 6.2% (31/503) at baseline and 6.1% (16/264) at 7 months. Median time from test to treatment was 15 h. Interviews suggested low test uptake was associated with not feeling at risk, perceptions of stigma, and little knowledge of sexually transmitted infections (STIs).\ud \ud Conclusions\ud Despite high C. trachomatis rates at baseline and follow-up, uptake of testing was low. Like many countries, England urgently needs better sex education, including making STI testing routine/normal.\ud \ud Trial registration ISRCTN58038795

ObjectiveTo estimate the impact of using the Aptima messenger RNA (mRNA) high-risk human papilloma virus (HR-HPV) assay versus a DNA HR-HPV assay in a primary HPV cervical screening programme.DesignOne hypothetical cohort followed for 3 years through HPV primary cervical screening.SettingEngland.ParticipantsA hypothetical cohort of women aged 25–65 years tested in the National Health Service (NHS) Cervical Screening Programme (CSP) for first call or routine recall testing.MethodsA decision tree parameterised with data from the CSP (2017/18) and the HORIZON study. Uncertainty analyses were conducted using data from the FOCAL and GAST studies, other DNA HPV tests in addition to one-way and probabilistic sensitivity and scenarios analyses, to test the robustness of results.InterventionsAptima mRNA HR-HPV assay and a DNA HR-HPV assay (cobas 4800 HPV assay).Main outcome measuresPrimary: total colposcopies and total costs for the cohort. Secondary: total HPV and cytology tests, number lost to follow-up.ResultsAt baseline for a population of 2.25 million women, an estimated £15.4 million (95% credibility intervals (CI) £6.5 to 24.1 million) could be saved and 28 009 (95% CI 27 499 to 28 527) unnecessary colposcopies averted if Aptima mRNA assays are used instead of a DNA assay, with 90 605 fewer unnecessary HR-HPV and 253 477 cytology tests performed. These savings are due to a lower number of HPV positive samples in the mRNA arm. When data from other primary HPV screening trials were compared, results indicated that using the Aptima mRNA assay generated cost savings and reduced testing in every scenario.ConclusionUsing the Aptima mRNA assay versus a DNA assay would almost certainly yield cost savings and reduce unnecessary testing and procedures, benefiting the NHS and women in the CSP.

ObjectivesTo quantify the costs, benefits and cost-effectiveness of three multipathogen point-of-care (POC) testing strategies for detecting common sexually transmitted infections (STIs) compared with standard laboratory testing.DesignModelling study.SettingGenitourinary medicine (GUM) services in England.PopulationA hypothetical cohort of 965 988 people, representing the annual number attending GUM services symptomatic of lower genitourinary tract infection.InterventionsThe decision tree model considered costs and reimbursement to GUM services associated with diagnosing and managing STIs. Three strategies using hypothetical point-of-care tests (POCTs) were compared with standard care (SC) using laboratory-based testing. The strategies were: A) dual POCT forChlamydia trachomatis(CT) andNeisseria gonorrhoeae(NG); B) triplex POCT for CT-NG andMycoplasma genitalium(MG); C) quadruplex POCT for CT-NG-MG andTrichomonas vaginalis(TV). Data came from published literature and unpublished estimates.Primary and secondary outcome measuresPrimary outcomes were total costs and benefits (quality-adjusted life years (QALYs)) for each strategy (2016 GB, £) and associated incremental cost-effectiveness ratios (ICERs) between each of the POC strategies and SC. Secondary outcomes were inappropriate treatment of STIs, onward STI transmission, pelvic inflammatory disease in women, time to cure and total attendances.ResultsIn the base-case analysis, POC strategy C, a quadruplex POCT, was the most cost-effective relative to the other strategies, with an ICER of £36 585 per QALY gained compared with SC when using microcosting, and cost-savings of £26 451 382 when using tariff costing. POC strategy C also generated the most benefits, with 240 467 fewer clinic attendances, 808 fewer onward STI transmissions and 235 135 averted inappropriate treatments compared with SC.ConclusionsMany benefits can be achieved by using multipathogen POCTs to improve STI diagnosis and management. Further evidence is needed on the underlying prevalence of STIs and SC delivery in the UK to reduce uncertainty in economic analyses.

Sexually active young people attending London further education (FE) colleges have high rates of chlamydia, but screening rates are low. We will conduct a cluster randomised feasibility trial of frequent, rapid, on-site chlamydia testing and same-day treatment (Test and Treat (TnT)) in six FE colleges (with parallel qualitative and economic assessments) to assess the feasibility of conducting a future trial to investigate if TnT reduces chlamydia rates. We will recruit 80 sexually active students aged 16–24 years from public areas at each of six colleges. All participants (total n = 480) will be asked to provide samples (urine for males, self-taken vaginal swabs for females) and complete questionnaires on sexual lifestyle and healthcare use at baseline and after 7 months. Participants will be informed that baseline samples will not be tested for 7 months and be advised to get screened separately. Colleges will be randomly allocated to the intervention (TnT) or the control group (no TnT). One and 4 months after recruitment, participants at each intervention college (n = 3) will be texted and invited for on-site chlamydia tests using the 90-min Cepheid GeneXpert system. Students with positive results will be asked to see a visiting nurse health adviser for same-day treatment and partner notification, (backed by genitourinary medicine follow-up). Participants in control colleges (n = 3) will receive ‘thank you’ texts 1 and 4 months after recruitment. Seven months after recruitment, participants from both groups will be invited to complete questionnaires and provide samples for TnT. All samples will be tested, and same-day treatment offered to students with positive results. Acceptability of TnT will be assessed by qualitative interviews of purposively sampled students (n = 30) and college staff (n = 12). We will collect data on costs of TnT and usual healthcare. Findings will provide key values to inform feasibility, sample size and timescales of a future definitive trial of TnT in FE colleges, including: International Standard Randomised Controlled Trials Registry, ID: ISRCTN58038795 , Registered on 31 August 2016.

Introduction In sexual health services, availability of rapid and accurate point-of-care tests (POCTs) may enable major improvements in care pathway efficiencies and outcomes. Previous economic evaluations of nucleic acid amplification test (NAAT) POCTs for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) indicate they may provide a cost-effective strategy for screening genitourinary medicine (GUM) attendees. We estimated costs, benefits and cost-effectiveness of three strategies using accurate, rapid NAAT POCTs that could detect different combinations of common multiple sexually transmitted infections (mSTIs) compared with standard care (SC; laboratory-based CT/NG NAAT). Methods A decision tree was constructed to simulate a hypothetical cohort of 9 65 988 patients, representing annual numbers of GUM attendees in England, symptomatic for lower genitourinary tract infection. The model considered delivery costs (micro-costing) and reimbursement (tariff) to GUM services associated with diagnosing and managing STIs. POCT strategies compared to SC were: A) POCT for CT and NG; B) POCT for CT-NG and Mycoplasma genitalium (MG); C) POCT for CT-NG-MG and Trichomonas vaginalis. Data came from published literature and unpublished estimates. Results SC was cheaper than all POCT strategies when micro-costing, but POCT C was the cheapest strategy for tariff costings. POCT C’s incremental cost-effectiveness ratio (ICER) was £36 585 per quality-adjusted life year (QALY) gained compared to SC when micro-costing; it was cost-saving (by £26,451,382) when tariff costing was applied. POCT C also generated most benefits, with 2 40 467 fewer clinic attendances, 808 fewer onward STI transmissions, and 2 35 135 averted inappropriate treatments compared to SC. Conclusion POCTs that detect STI diagnoses may be cost-effective, cost-saving and improve patient management. However, there is variation by costing strategy, patient population, clinical setting and patient pathways. Further evidence is needed to populate model parameters to reduce uncertainty in economic analyses.

Introduction Antimicrobial resistance (AMR) threatens successful Neisseria gonorrhoeae (NG) treatment and WHO recommends specific NG treatments be used only if ≤5% circulating strains are resistant to them. Ceftriaxone plus azithromycin dual therapy, currently recommended, has few practical alternatives should ceftriaxone resistance become widespread, and azithromycin use is undermined also by AMR emergence. Point-of-care tests for AMR (POCTR) at NG diagnosis may enable a significant proportion of NG infections to be successfully treated using previously abandoned regimens, thereby sparing ceftriaxone use. We assess cost-effectiveness of British standard of care (SC) vs hypothetically accurate POCTR strategies used to either optimise dual therapy or allow monotherapy in patients diagnosed with NG. Methods A decision tree was constructed to simulate a hypothetical cohort of 38,870 NG-diagnosed GUM clinic attendees, representing 2015 annual numbers in England. Costs of AMR testing, NG treatment and return attendances were considered for SC and dual therapy optimisation strategies: A) POCTR for ciprofloxacin only; B) POCTR for azithromycin followed by POCTR for ciprofloxacin; C) POCTR for ciprofloxacin followed by POCTR for azithromycin; and monotherapy POCTR strategies for: D) azithromycin; E) ciprofloxacin; F) amoxicillin/probenecid. Results Total costs for all POCTR strategies were more expensive than SC. Strategy B (where azithromycin-ceftriaxone remains largely first-line) was most cost-effective for avoiding sub-optimal treatments, costing £4532 per optimal treatment gained. Strategy D was most cost-effective for ceftriaxone use avoidance (98% decrease [713 vs 38 870] compared to SC), costing £16.27 per ceftriaxone-sparing treatment gained, but resulting in 7 treatment failures ( vs 0 in SC) due to false AMR POCTR results. Conclusion Specific POCTR strategies enable optimal treatment and ceftriaxone use avoidance, thus promoting antibiotic stewardship. The public health impact of sparing ceftriaxone whilst increasing treatment failures must be investigated.

Objective To create a mathematical model to investigate the treatment impact and economic implications of introducing an antimicrobial resistance point-of-care test (AMR POCT) for gonorrhoea as a way of extending the life of current last-line treatments. Design Modelling study. Setting England. Population Patients accessing sexual health services. Interventions Incremental impact of introducing a hypothetical AMR POCT that could detect susceptibility to previous first-line antibiotics, for example, ciprofloxacin or penicillin, so that patients are given more tailored treatment, compared with the current situation where all patients are given therapy with ceftriaxone and azithromycin. The hypothetical intervention was assessed using a mathematical model developed in Excel. The model included initial and follow-up attendances, loss to follow-up, use of standard or tailored treatment, time taken to treatment and the costs of testing and treatment. Main outcome measures Number of doses of ceftriaxone saved, mean time to most appropriate treatment, mean number of visits per (infected) patient, number of patients lost to follow-up and total cost of testing. Results In the current situation, an estimated 33 431 ceftriaxone treatments are administered annually and 792 gonococcal infections remain untreated due to loss to follow-up. The use of an AMR POCT for ciprofloxacin could reduce these ceftriaxone treatments by 66%, and for an AMR POCT for penicillin by 79%. The mean time for patients receiving an antibiotic treatment is reduced by 2 days in scenarios including POCT and no positive patients remain untreated through eliminating loss to follow-up. Such POCTs are estimated to add £34 million to testing costs, but this does not take into account reductions in costs of repeat attendances and the reuse of older, cheaper antimicrobials. Conclusions The introduction of AMR POCT could allow clinicians to discern between the majority of gonorrhoea-positive patients with strains that could be treated with older, previously abandoned first-line treatments, and those requiring our current last-line dual therapy. Such tests could extend the useful life of dual ceftriaxone and azithromycin therapy, thus pushing back the time when gonorrhoea may become untreatable.

Existing Point-of-care tests (POCT) to help identify infection-related causes of illness can complement diagnostic and disposition decisions in children attending emergency departments.(1) Evidence-based clinical algorithms can integrate such POCT to aid in the admission and discharge decision process. Paediatric studies validating these tools are scarce, with very few studies conducted in UK centres.(2-5) POCT can be based on host infection markers (e.g. finger prick tests for C-reactive protein (CRP) to help decide if the patient has a bacterial or viral infection) or pathogen detection tests (e.g. throat/nose swabs to rapidly diagnose viral infections such as RSV or influenza). This article is protected by copyright. All rights reserved.

In 2010/2011, regional commissioners withdrew payment for the fixed-dose combination Combivir, forcing a switch to component drugs. This was deemed clinically acceptable and annual savings of £44 k expected. We estimated the true costs of switching and examined patient outcomes. Information for 46 patients using Combivir was extracted from case notes for each clinical contact in the 12 months pre- and post-switch (clinician seen, tests, antiretrovirals). Post-switch care costs £93/patient more annually versus pre-switch (95% CI £424 to £609), yielding £4278/year more post-switch for all patients. Drug and pathology costs were more expensive post-switch and extra clinical visits required. None of these results were statistically significant. Forty-two per cent of patients switched directly or in the subsequent year to an alternative fixed-dose combination rather than generics. Costs in this group were significantly higher post-switch driven by drug cost. Six patients (13%) reported problems with the switch including confusion around dosing and new side effects. As less-expensive generic antiretroviral drugs become available, it may appear cheaper to switch from fixed-dose combinations to component drugs. However, the additional clinical costs involved may outweigh the initial cost savings of the drugs and switching may cause confusion for some patients, risking loss of adherence.

Purpose of review Mycoplasma genitalium is a sexually transmitted infection that causes significant morbidity in men and women and is a co-factor in HIV transmission. However, commercial diagnostic tests are not generally available for M. genitalium and sub-optimal treatment is often given. We review the literature on the burden of infection, how it may present in clinical practice and the effectiveness of current treatment regimens. Recent findings In-vivo and in-vitro data strongly suggest that M. genitalium is an important cause of urethritis, cervicitis, pelvic inflammatory disease and potentially asymptomatic proctitis. Studies now consistently demonstrate suboptimal eradication rates with the current treatment regimens recommended first line for the treatment of nongonococcal urethritis. Concurrently, there has been a rapid emergence of antibiotic resistance in M. genitalium, with macrolide resistance now appearing to be endemic in some centres, and quinolone resistance is beginning to emerge. Summary In the absence of specific M. genitalium diagnostic and antimicrobial resistance testing, azithromycin 1 g should not be used for the management of patients with symptomatic disease potentially caused by M. genitalium. This review offers an alternative evidence-based approach to managing such patients that should, theoretically, reduce the risk of the development of antimicrobial resistance.

OBJECTIVES: To estimate the costs and benefits of clinical pathways incorporating a point of care (POC) nucleic acid amplification test (NAAT) for chlamydia and gonorrhoea in genitourinary medicine (GUM) clinics compared with standard off-site laboratory testing. METHOD: We simulated 1.2 million GUM clinic attendees in England. A simulation in Microsoft Excel was developed to compare existing standard pathways of management for chlamydia and gonorrhoea with a POC NAAT. We conducted scenario analyses to evaluate the robustness of the model findings. The primary outcome was the incremental cost-effectiveness ratio. Secondary outcomes included the number of inappropriate treatments, complications and transmissions averted. RESULTS: The baseline cost of using the point of POC NAAT was £103.9 million compared with £115.6 million for standard care. The POC NAAT was also associated with a small increase of 46 quality adjusted life years, making the new test both more effective and cheaper. Over 95 000 inappropriate treatments might be avoided by using a POC NAAT. Patients receive diagnosis and treatment on the same day as testing, which may also prevent 189 cases of pelvic inflammatory disease and 17 561 onward transmissions annually. DISCUSSION: Replacing standard laboratory tests for chlamydia and gonorrhoea with a POC test could be cost saving and patients would benefit from more accurate diagnosis and less unnecessary treatment. Overtreatment currently accounts for about a tenth of the reported treatments for chlamydia and gonorrhoea and POC NAATs would effectively eliminate the need for presumptive treatment.

The performance of the Enigma MiniLab assay for influenza A and B viruses and respiratory syncytial virus (RSV) was compared to a centralized laboratory respiratory virus panel. The positive and negative percent agreement for influenza A virus, influenza B virus, and RSV were 79.2% (95% confidence interval [95% CI], 57.8 to 92.9%) and 99.4% (95% CI, 98.4 to 99.9), 100% (95% CI, 47.8 to 100%) and 100% (95% CI, 99.3 to 100%), 98.5% (95% CI, 94.6 to 99.8%) and 94.5% (95% CI, 91.9 to 96.4%), respectively.

In this study we assessed the incidence of voiding dysfunction in women 6 months after undergoing a tension-free vaginal tape (TVT) procedure. Logistic regression was then used to look for significantly associated factors from a range of patient, urodynamic and surgical variables. From a group of 267 women we identified 22 (8%) who needed to perform daily intermittent self-catheterisation (ISC) as a result of the TVT surgery. When potential predictive factors were examined individually there were three that appeared to be associated with the need to use ISC: menopausal status,previous incontinence surgery and the centile score for average voiding flow rate (as derived from a volume--flow rate nomogram). Following multivariate logistic regression this flow rate centile score showed the strongest association with post-TVT voiding dysfunction, the likelihood of needing ISC increasing as the centile score fell. This factor has not previously been described but is readily assessed pre-operatively and may be useful in case selection for TVT.

BackgroundThe burden of Congenital Rubella Syndrome (CRS) is typically underestimated in routine surveillance. Updated estimates are needed following the recent WHO position paper on rubella and recent GAVI initiatives, funding rubella vaccination in eligible countries. Previous estimates considered the year 1996 and only 78 (developing) countries.MethodsWe reviewed the literature to identify rubella seroprevalence studies conducted before countries introduced rubella-containing vaccination (RCV). These data and the estimated vaccination coverage in the routine schedule and mass campaigns were incorporated in mathematical models to estimate the CRS incidence in 1996 and 2000–2010 for each country, region and globally.ResultsThe estimated CRS decreased in the three regions (Americas, Europe and Eastern Mediterranean) which had introduced widespread RCV by 2010, reaching ConclusionsWhilst falling dramatically in the Americas, Europe and the Eastern Mediterranean after vaccination, the estimated CRS incidence remains high elsewhere. Well-conducted seroprevalence studies can help to improve the reliability of these estimates and monitor the impact of rubella vaccination.

Purpose: To investigate the potential for intensity-modulated radiotherapy (IMRT) to spare the bowel in rectal tumors. Methods and Materials: The targets (pelvic nodal and rectal volumes), bowel, and bladder were outlined in 5 patients. All had conventional, three-dimensional conformal RT and forward-planned multisegment three-field IMRT plans compared with inverse-planned simultaneous integrated boost nine-field equally spaced IMRT plans. Equally spaced seven-field and five-field and five-field, customized, segmented IMRT plans were also evaluated. Results: Ninety-five percent of the prescribed dose covered at least 95% of both planning target volumes using all but the conventional plan (mean primary and pelvic planning target volume receiving 95% of the prescribed dose was 32.8 ± 13.7 Gy and 23.7 ± 4.87 Gy, respectively), reflecting a significant lack of coverage. The three-field forward planned IMRT plans reduced the volume of bowel irradiated to 45 Gy and 50 Gy by 26% ± 16% and 42% ± 27% compared with three-dimensional conformal RT. Additional reductions to 69 ± 51 cm 3 to 45 Gy and 20 ± 21 cm 3 to 50 Gy were obtained with the nine-field equally spaced IMRT plans—64% ± 11% and 64% ± 20% reductions compared with three-dimensional conformal RT. Reducing the number of beams and customizing the angles for the five-field equally spaced IMRT plan did not significantly reduce bowel sparing. Conclusion: The bowel volume irradiated to 45 Gy and 50 Gy was significantly reduced with IMRT, which could potentially lead to less bowel toxicity. Reducing the number of beams did not reduce bowel sparing and the five-field customized segmented IMRT plan is a reasonable technique to be tested in clinical trials.

Objective The objective was to begin the process of developing an antenatal risk scoring system, as a first steptowards examining whether elective Caesarean section for women at high risk of injury could be an effectiveand acceptable intervention.Design Retrospective study.Setting Tertiary maternity unit in the UK.Population One hundred and twenty-three women who sustained an obstetric anal sphincter injury (OASI)and 123 controls without OASI.Methods Case notes of women with a third or fourth degree tear between 1997 and 1999 were examined forrisk factors. Controls matched for age and week of delivery were identified from the maternity record databaseand case records reviewed for the presence of risk factors. Unweighted and weighted risk scores were producedusing odds ratios, and compared between cases and controls. Receiver operating characteristics (ROC) curveanalysis of the risk scores was performed to discriminate between cases and controls and to calculate thesensitivity and specificity of each scoring system.Main outcome measures Odds ratio (OR) and 95% confidence interval (CI) for each risk factor. Sensitivityand specificity from ROC curves for weighted and unweighted risk score.Results Among the cases there were more nulliparous women (OR 1.77; CI 1.05–2.99) and a trend towardsmore women with an episiotomy (OR 1.57; CI 0.99–2.47). Among women with sphincter injury, trendstowards more epidurals (OR 1.64; CI 0.97–2.75), and more babies weighing more than 4000 g among (OR1.45; CI 0.85–2.49) were noted. The median unweighted risk score was 2 for cases and 2 for controls (P ¼0.05), while the weighted risk score was 2.1 and 1.37 (P ¼ 0.03), respectively. The ROC curves approx-imated to a straight line demonstrating very poor discrimination between cases and controls.Conclusion The predictive test performed poorly, suggesting that the risk factors identified do not exert alarge enough effect in a cohort of this size.INTRODUCTIONObstetric anal sphincter injuries (OASI; third and fourthdegree tears) complicate 0.5–15% of vaginal deliveries

Objectives: To undertake a systematic review to obtain estimates of genital Chlamydia trachomatis prevalence in various populations in the United Kingdom and Ireland; to determine which populations have the highest rates of infection; and to explore the most important determinants of infection. Methods: Electronic databases were searched using the keywords "chlamydia" and "England," "Wales," "UK," "Scotland," "Ireland," or "Britain." Additional unpublished data and references were solicited from experts. Studies were included in the analysis if C trachomatis prevalence was reported, and if they met inclusion criteria. Nine variables identified as potentially important descriptors of chlamydia prevalence were extracted from each study and analysed using various logistic regression models. Only studies reporting prevalence in female populations were included in the models, because there were few data from males. Results: 357 studies were identified using the search methods, 90 of which met inclusion criteria, and 19 of which contributed to the final model. The most influential variables on prevalence were age and setting of the population tested. In general practice surgeries, the under 20 year old age group had an estimated prevalence of 8.1% (95% CI 6.5 to 9.9), 20–24 year olds 5.2% (95% CI 4.3 to 6.3), 25–29 year olds 2.6% (95% CI 2.0 to 3.3), decreasing to 1.4% (95% CI 1.0 to 1.9) in those aged over 30 years. Overall, healthcare settings had higher prevalence estimates than population based studies. For example, among under 20 year olds, estimates were 17.3% (95% CI 13.6 to 21.8) in genitourinary medicine clinics, 12.6% (95% CI 6.4 to 23.2) in antenatal clinics, 12.3% (95% CI 9.8 to 15.3) in termination of pregnancy clinics, 10.7% (95% CI 8.3 to 13.8) in youth clinics, 10.0% (95% CI 8.7 to 11.5) in family planning clinics, and 8.1% (95% CI 6.5 to 9.9) in general practice, compared to 5.0% (95% CI 3.2 to 7.6) in population based studies. The type of test, specimen used, date, and location of test were not strongly associated with chlamydia prevalence. Conclusion: The chlamydia prevalence estimates by age and setting from the model may be used to inform chlamydia screening strategies. The systematic review revealed much heterogeneity in the studies identified, but with clear patterns of prevalence. It also indicated gaps in the knowledge about chlamydia prevalence in certain subgroups such as men and the general population.

OBJECTIVES: To estimate the average cost per screening offer, cost per testing episode and cost per chlamydia positive episode for an opportunistic chlamydia screening programme (including partner management), and to explore the uncertainty of parameter assumptions, based on the costs to the healthcare system. METHODS: A decision tree was constructed and parameterised using empirical data from a chlamydia screening pilot study and other sources. The model was run using baseline data from the pilot, and univariate and multivariate sensitivity analyses were conducted. RESULTS: The total estimated cost for offering screening over 12 months to 33,215 females aged 16-24 was 493,412 pounds . The average cost (with partner management) was 14.88 pounds per screening offer (90% credibility interval (CI) 10.34 to 18.56), 21.83 pounds per testing episode (90% CI 18.16 to 24.20), and 38.36 pounds per positive episode (90% CI 33.97 to 42.25). The proportion of individuals accepting screening, the clinician (general practitioner/nurse) time and their relative involvement in discussing screening, the test cost, the time to notify patients of their results, and the receptionist time recruiting patients had the greatest impact on the outcomes in both the univariate and multivariate sensitivity analyses. CONCLUSIONS: Results from this costing study may be used to inform resource allocation for current and future chlamydia screening programme implementation.

Objectives To examine the practice of making an episiotomy and to determine any differences in practice between professional groups. Design A prospective survey. Setting A large tertiary referral obstetric hospital and the obstetric department of a district general hospital. Population All staff routinely involved in the care of women in labour. Methods A novel validated pictorial questionnaire was designed, validated and distributed to the study population. Differences in outcome measures were compared by profession and by seniority. Main outcome measures Measurements taken from the questionnaire: the length of episiotomy drawn; the distance from the sagittal plane at which the episiotomy was begun; and the angle of the episiotomy from the sagittal plane. Results Fifty doctors and 78 midwives completed the forms. Median distance of the episiotomy from the midline was 0 mm (−2 to 11). Episiotomies drawn by doctors were significantly longer and more angled than those drawn by midwives (P = 0.002 and P = 0.001). Sixteen percent of doctors and 1% of midwives drew an episiotomy longer than 20 mm (difference 15%, 95% CI 6 to 24). Twenty-three percent of midwives and 2% of doctors drew an episiotomy angled 30° or less (difference 21%, 95% CI 9 to 34). Conclusions This study has demonstrated differences in the reporting of episiotomy practice by doctors and midwives. Theoretically, the differences demonstrated could predispose to a greater risk of anal sphincter injuries. These data need to be confirmed by observational studies of actual practice and by studies to investigate the mechanics of sphincter injury during childbirth.

BACKGROUND: Many people with sexually transmitted diseases (STDs) in Lima, Peru, seek treatment in pharmacies. GOAL: The goal was to assess the cost-effectiveness of training pharmacy workers in syndromic management of STDs. STUDY DESIGN: Cost-effectiveness from both the program and societal perspectives was determined on the basis of study costs, societal costs (cost of medicine), and the number of cases adequately managed. The latter was calculated from estimated incidence, proportion of symptomatic patients, proportion seeking treatment in pharmacies, and proportion of cases adequately managed in both comparison and intervention districts. Univariate and multivariate sensitivity analyses were performed. RESULTS: Under base-case assumptions, from the societal perspective the intervention saved an estimated US$1.51 per case adequately managed; from the program perspective, it cost an estimated US$3.67 per case adequately managed. In the sensitivity analyses, the proportion of females with vaginal discharge or pelvic inflammatory disease who seek treatment in pharmacies had the greatest impact on the estimated cost-effectiveness, along with the medication costs under the societal perspective. CONCLUSION: Training pharmacists in syndromic management of STDs appears to be cost-effective when only program costs are used and cost-saving from the societal perspective. Our methods provide a template for assessing the cost-effectiveness of managing STD syndromes, on the basis of indirect estimates of effectiveness.

Antenatal screening for postpartum urinary incontinence in nulliparous women: a pilot study. Objective : To examine the utility of joint mobility scoring (JMS) as a screening test for postpartum urinary incontinence. Study Design : A prospective cohort study in a teaching hospital involving 150 nulliparous women. JMS was calculated. The incidence of incontinence and pad use was recorded. Univariate and multiple logistic regression analyses were used to identify factors independently associated with incontinence. Results : Hundred and three women completed the study. 43.7% of subjects were incontinent antenatally and 4.9% remained incontinent at the study end. JMS was normally distributed and similar in continent and incontinent women. Elbow hyperextension (>180°) was associated with postnatal incontinence (odds ratio 10.6; 95% CI 1.24, 90.8). Elbow hyperextension had a sensitivity of 80%, specificity of 75%, positive predictive value of 14%, and negative predictive value of 99% for postnatal incontinence. Conclusion : Joint hypermobility score is not a useful screening test. Elbow hyperextension is associated with an increased likelihood of postnatal urinary incontinence. It is unclear whether this test has clinical utility outside a research setting.

OBJECTIVE: To create a mathematical model to investigate the treatment impact and economic implications of introducing an antimicrobial resistance point-of-care test (AMR POCT) for gonorrhoea as a way of extending the life of current last-line treatments.DESIGN: Modelling study.SETTING: England.POPULATION: Patients accessing sexual health services.INTERVENTIONS: Incremental impact of introducing a hypothetical AMR POCT that could detect susceptibility to previous first-line antibiotics, for example, ciprofloxacin or penicillin, so that patients are given more tailored treatment, compared with the current situation where all patients are given therapy with ceftriaxone and azithromycin. The hypothetical intervention was assessed using a mathematical model developed in Excel. The model included initial and follow-up attendances, loss to follow-up, use of standard or tailored treatment, time taken to treatment and the costs of testing and treatment.MAIN OUTCOME MEASURES: Number of doses of ceftriaxone saved, mean time to most appropriate treatment, mean number of visits per (infected) patient, number of patients lost to follow-up and total cost of testing.RESULTS: In the current situation, an estimated 33 431 ceftriaxone treatments are administered annually and 792 gonococcal infections remain untreated due to loss to follow-up. The use of an AMR POCT for ciprofloxacin could reduce these ceftriaxone treatments by 66%, and for an AMR POCT for penicillin by 79%. The mean time for patients receiving an antibiotic treatment is reduced by 2 days in scenarios including POCT and no positive patients remain untreated through eliminating loss to follow-up. Such POCTs are estimated to add £34 million to testing costs, but this does not take into account reductions in costs of repeat attendances and the reuse of older, cheaper antimicrobials.CONCLUSIONS: The introduction of AMR POCT could allow clinicians to discern between the majority of gonorrhoea-positive patients with strains that could be treated with older, previously abandoned first-line treatments, and those requiring our current last-line dual therapy. Such tests could extend the useful life of dual ceftriaxone and azithromycin therapy, thus pushing back the time when gonorrhoea may become untreatable.

Objective To test the hypothesis that compliance with oxybutynin would be improved if the severity of dry mouth could be reduced, thus leading to improved urinary symptom response and improved outcome, in a randomized, controlled trial of oxybutynin with or without salivary stimulant pastilles in patients with detrusor instability. Patients and methods Sixty-seven women with detrusor instability were randomized to a variable dose regimen of oxybutynin with (37) or without (30) salivary stimulant pastilles for 8 weeks. Patients were asked to complete a baseline voiding diary. In weeks 1 and 2, patients were encouraged to adjust the dose of oxybutynin themselves to achieve optimum symptomatic control. A second diary was completed in the sixth week and patients were reviewed at 8 weeks. The outcome measures were the compliance rate, follow-up attendance rate, maximum dose of medication, changes in voiding and incontinence episodes, and changes in severity of urgency and of dry mouth symptoms between the first and sixth week. Results Of the 67 women, 32 (47%) completed the study; the proportion completing was the same in both groups. Four patients had stopped the medication and there was no difference in the distribution of maximum dosage achieved between the groups. Both groups reported a reduced severity of urgency symptoms and increased severity of dry mouth. There were no differences in reported symptom change between the groups during the study. Conclusions The combination of oxybutynin and salivary stimulant pastilles does not improve compliance or symptom relief compared with oxybutynin alone; it does not allow a greater dose of oxybutynin to be tolerated.

Objectives To estimate the costs and potential efficiency gains of changing the frequency of clinic appointments and drug dispensing arrangements for stable HIV patients compared to the costs of hospital pharmacy dispensing and home delivery. Methods We estimated the annual costs per patient (HIV clinic visits and either first-line treatment or a common second-line regimen, with some patients switching to a second-line regimen during the year). The cost of three-, four- and six-monthly clinic appointments and drug supply was estimated assuming hospital dispensing (incurring value-added tax) and home delivery. Three-monthly appointments and hospital drug dispensing (baseline) were compared to other strategies. Results The baseline was the most costly option (£10,587 if first-line treatment and no switch to second-line regimen). Moving to six-monthly appointments and home delivery yielded savings of £1883 per patient annually. Assuming patients start on different regimens and may switch to second-line therapies, six-monthly appointments and three-monthly home delivery of drugs is the least expensive option and could result in nearly £2000 savings per patient. This translates to annual cost reduction of about £8 million for the estimated 4000 eligible patients not currently on home delivery in London, England. Conclusions Different appointment schedules and drug supply options should be considered for stable HIV patients based on efficiency gains. However, this should be assessed for individual patients to meet their needs, especially around adherence and patient support.

Background Pelvic organ prolapse is common, with some degree of prolapse seen in up to 50% of parous women in a clinic setting, although many are asymptomatic. The use of pessaries (a passive mechanical device designed to support the vagina) to treat prolapse is very common, and up to 77% of clinicians use pessaries for the first line management of prolapse. A number of symptoms may be associated with prolapse and treatments include surgery, pessaries and conservative therapies. A variety of pessaries are described which aim to alleviate the symptoms of prolapse and avert or delay the need for surgery. Objectives To determine the effectiveness of pessaries (mechanical devices) for pelvic organ prolapse. Search methods We searched the Cochrane Incontinence Group Specialised Register of trials (searched 13 March 2012), which includes searches of CENTRAL, MEDLINE, PREMEDLINE and handsearching of conference proceedings, and handsearched the abstracts of two relevant conferences held in 2011. We also searched the reference lists of relevant articles. Selection criteria Randomised and quasi-randomised controlled trials which included a pessary for pelvic organ prolapse in one arm of the study. Data collection and analysis Abstracts were assessed independently by two authors with arbitration from a third if necessary. Data extraction was completed independently for included studies by two review authors. Main results To date there is only one published randomised controlled trial assessing the use of pessaries in the treatment of pelvic organ prolapse. Authors' conclusions The review authors identified one randomised controlled trial comparing ring and Gellhorn pessaries. The results of the trial showed that both pessaries were effective for the approximately 60% of women who completed the study with no significant differences identified between the two types of pessary. However, methodological flaws were noted in the trial, as elaborated under risk of bias assessment. There is no consensus on the use of different types of device, the indications nor the pattern of replacement and follow-up care. There is an urgent need for randomised studies to address the use of pessaries in comparison with no treatment, surgery and conservative measures.

Objectives To describe healthcare settings attended by women with clinical pelvic inflammatory disease (PID), to calculate the cost of a PID episode and to estimate how many cases could be prevented in London annually at current chlamydia screening levels. Methods An ethnically diverse sample of 2259 16–24 year old, sexually active, female London students were recruited to a chlamydia screening trial in 2004–2006 of whom 94% (2115) were followed up after 12 months for incidence of PID. A cost analysis examined healthcare settings attended by women with PID, the cost of an episode of PID and the number of cases of PID in London due to untreated chlamydia at baseline that could be prevented per year at 2009 annual screening levels. Results Of 35 PID cases, 17 (47%) first presented in general practice, 15 (42%) at a genitourinary medicine clinic, two elsewhere and one was admitted to hospital. The average number of consultations for a PID episode was 2.0 (range 1–4) and the average cost was £163 (range £29–960). Assuming 414 345 sexually active women aged 16–24 in London, 6% chlamydia prevalence at baseline and a 7.3% difference in PID rates between screened and unscreened chlamydia positives, 391 (95% CI −44 to 882) cases of chlamydia-associated PID costing £63 733 could be prevented each year in London at 21.5% 2009 annual screening levels. Conclusions Most women with PID were managed in the community. The number and cost of PID cases prevented by a single annual chlamydia screen is low suggesting that cost effectiveness may depend mainly on the prevention of long-term sequelae.

Objectives To compare the cost, cost effectiveness, and sex equity of different intervention strategies within the English National Chlamydia Screening Programme. To develop a tool for calculating cost effectiveness of chlamydia control programmes at a local, national, or international level. Design An economic and mathematical modelling study with cost effectiveness analysis. Costs were restricted to those of screening and partner notification from the perspective of the NHS and excluded patient costs, the costs of reinfection, and costs of complications arising from initial infection. Setting England. Population Individuals eligible for the National Chlamydia Screening Programme. Main outcome measures Cost effectiveness of National Chlamydia Screening Programme in 2008–9 (as cost per individual tested, cost per positive diagnosis, total cost of screening, number screened, number infected, sex ratio of those tested and treated). Comparison of baseline programme with two different interventions—(i) increased coverage of primary screening in men and (ii) increased efficacy of partner notification. Results In 2008–9 screening was estimated to cost about £46.3m in total and £506 per infection treated. Provision for partner notification within the screening programme cost between £9 and £27 per index case, excluding treatment and testing. The model results suggest that increasing male screening coverage from 8% (baseline value) to 24% (to match female coverage) would cost an extra £22.9m and increase the cost per infection treated to £528. In contrast, increasing partner notification efficacy from 0.4 (baseline value) to 0.8 partners per index case would cost an extra £3.3m and would reduce the cost per infection diagnosed to £449. Increasing screening coverage to 24% in men would cost over six times as much as increasing partner notification to 0.8 but only treat twice as many additional infections. Conclusions In the English National Chlamydia Screening Programme increasing the effectiveness of partner notification is likely to cost less than increasing male coverage but also improve the ratio of women to men diagnosed. Further evaluation of the cost effectiveness of partner notification and screening is urgently needed. The spreadsheet tool developed in this study can be easily modified for use in other settings to evaluate chlamydia control programmes.

Objective To develop and validate a pictorial chart that documents ultrasound examination of the anal sphincter. Design A new pictorial chart (Liverpool Ultrasound Pictorial Chart [LUPIC]) depicting the normal anatomy of the anal sphincter was developed. Methods To validate LUPIC, two observers documented the findings of 296 endoanal scans. Reliability was assessed between observers using kappa agreement for presence and position of sphincter defects. To validate the use of LUPIC by different observers, a video of ten endoanal ultrasound scans was reviewed by our local expert (gold standard). Seven clinicians underwent test-retest analysis. Kappa agreement was calculated to assess intra-observer and gold standard versus observer agreement for the overall presence of sphincter defects and compared with the gold standard. Complete agreement for the position and level of sphincter defects was assessed for the five abnormal scans. Main outcome measures Excellent agreement between the two observers was found for the presence (kappa 0.99), position and level of external anal sphincter defects documented using LUPIC. The intra-observer and gold standard versus observer kappa values of experienced clinicians (A–E) showed good agreement for the overall presence of sphincter defects. Complete agreement for the position and level of sphincter defects was found in 23 of 35 (66%) observations. Conclusions LUPIC is designed and validated method of documenting anal sphincter injury diagnosed by endoanal ultrasound. Standardisation of endoanal ultrasound findings by using LUPIC may help correlate the degree of damage with patient symptoms.

Several developed countries have initiated chlamydia screening programmes. Screening for a sexually transmitted infection has both direct individual and indirect population-wide effects. Mathematical models can incorporate these non-linear effects and estimate the likely impact of different screening programmes and identify areas where more data are needed.A stochastic, individual based dynamic network model, parameterised from UK screening studies and data on sexual behaviour and chlamydia epidemiology, was used to investigate the likely impact of opportunistic screening on chlamydia prevalence. Three main strategies were considered for25 year olds: (1) annual offer to women; (2) annual offer to women or if changed partner within last 6 months; (3) annual offer to men and women. Sensitivity analyses were performed for key screening parameters including uptake rate, targeted age range, percentage of partners notified, and screening interval.Under strategy 1, continuous opportunistic screening of women25 years of age is expected to reduce the population prevalence by over 50% after 5 years. Prevalence is also expected to decrease in unscreened older women and in men. For all three strategies screening those aged over 25 results in small additional reductions in prevalence. Including men led to a faster and greater reduction in overall prevalence, but involved approximately twice as many tests as strategy 1 and 10% more than strategy 2. The frequency of attendance at healthcare sites limits the number of opportunities to screen and the effect of changing the screening interval.The model suggests that continuous opportunistic screening at high uptake rates could significantly reduced chlamydia prevalence within a few years. Opportunistic programmes depend on regular attendance at healthcare providers, but there is a lack of high quality data on patterns of attendance. Inequalities in coverage may result in a less efficient and less equitable outcome.

Background A national chlamydia screening programme is currently being rolled out in the UK and other countries. However, much of the epidemiology remains poorly understood. In this paper we present a stochastic, individual based, dynamic sexual network model of chlamydia transmission and its parameterisation. Mathematical models provide a theoretical framework for understanding the key epidemiological features of chlamydia: sexual behaviour, health care seeking and transmission dynamics. Results The model parameters were estimated either directly or by systematic fitting to a variety of appropriate data sources. The fitted model was representative of sexual behaviour, chlamydia epidemiology and health care use in England. We were able to recapture the observed age distribution of chlamydia prevalence. Conclusion Estimating parameters for models of sexual behaviour and transmission of chlamydia is complex. Most of the parameter values are highly correlated, highly variable and there is little empirical evidence to inform estimates. We used a novel approach to estimate the rate of active treatment seeking, by combining data sources, which improved the credibility of the model results. The model structure is flexible and is broadly applicable to other developed world settings and provides a practical tool for public health decision makers.

Purpose: We examined bladder biopsies from women with interstitial cystitis/chronic pelvic pain syndrome (IC/CPPS) for the presence of bacterial and viral DNA sequences using polymerase chain reaction. Materials and Methods: Bladder biopsies were taken during cystoscopy from patients under investigation for IC/CPPS, or controls undergoing colposuspension for stress incontinence. Biopsies were snap frozen to −70C. After DNA extraction, polymerase chain reaction (PCR) using specific primers for the hypoxanthine-guanine phosphoribosyl transferase gene confirmed the presence of human DNA. PCR for bacterial and viral gene sequences was performed using specific primers. Positive reactions were repeated to confirm the signal. Results: A total of 92 patients with IC/CPPS (12 who met the National Institute of Diabetes and Digestive and Kidney Diseases criteria and 80 who did not) and 91 controls were recruited. PCR for hypoxanthine-guanine phosphoribosyl transferase gene was positive in all samples. PCR for the 16S ribosomal RNA gene, as well as for adenovirus, cytomegalovirus, herpes simplex virus types I and II, human papillomavirus (all subtypes) and Chlamydia trachomatis were negative in all samples. Conclusions: IC/CPPS is not associated with persistence of viral and bacterial DNA in the bladder. A chronic infective etiology for the condition is excluded by these findings.

Background Pelvic organ prolapse may occur in up to 50% of parous women. A variety of urinary, bowel and sexual symptoms may be associated with the prolapse. Objectives To determine the effects of the many different surgeries used in the management of pelvic organ prolapse. Search methods We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process and handsearching of journals and conference proceedings, healthcare-related bibliographic databases, handsearched conference proceedings (searched 20 August 2012), and reference lists of relevant articles. We also contacted researchers in the field. Selection criteria Randomised or quasi-randomised controlled trials that included surgical operations for pelvic organ prolapse. Data collection and analysis Trials were assessed and data extracted independently by two review authors. Six investigators were contacted for additional information with five responding. Main results Fifty-six randomised controlled trials were identified evaluating 5954 women. For upper vaginal prolapse (uterine or vault) abdominal sacral colpopexy was associated with a lower rate of recurrent vault prolapse on examination and painful intercourse than with vaginal sacrospinous colpopexy. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach. In single studies the sacral colpopexy had a higher success rate on examination and lower reoperation rate than high vaginal uterosacral suspension and transvaginal polypropylene mesh. Twenty-one trials compared a variety of surgical procedures for anterior compartment prolapse (cystocele). Ten compared native tissue repair with graft (absorbable and permanent mesh, biological grafts) repair for anterior compartment prolapse. Native tissue anterior repair was associated with more recurrent anterior compartment prolapse than when supplemented with a polyglactin (absorbable) mesh inlay (RR 1.39, 95% CI 1.02 to 1.90) or porcine dermis mesh inlay (RR 2.08, 95% CI 1.08 to 4.01), however there was no difference in post-operative awareness of prolapse after absorbable mesh (RR 0.96, 95% CI 0.33 to 2.81) or a biological graft (RR 1.21, 95% CI 0.64 to 2.30). Data on morbidity and other clinical outcomes were lacking. Standard anterior repair was associated with more anterior compartment prolapse on examination than for any polypropylene (permanent) mesh repair (RR 3.15, 95% CI 2.50 to 3.96). Awareness of prolapse was also higher after the anterior repair as compared to polypropylene mesh repair (28% versus 18%, RR 1.57, 95% CI 1.18 to 2.07). However, the reoperation rate for prolapse was similar at 14/459 (3%) after the native tissue repair compared to 6/470 (1.3%) (RR 2.18, 95% CI 0.93 to 5.10) after the anterior polypropylene mesh repair and no differences in quality of life data or de novo dyspareunia were identified. Blood loss (MD 64 ml, 95% CI 48 to 81), operating time (MD 19 min, 95% CI 16 to 21), recurrences in apical or posterior compartment (RR 1.9, 95% CI 1.0 to 3.4) and de novo stress urinary incontinence (RR 1.8, 95% CI 1.0 to 3.1) were significantly higher with transobturator meshes than for native tissue anterior repair. Mesh erosions were reported in 11.4% (64/563), with surgical interventions being performed in 6.8% (32/470). Data from three trials compared native tissue repairs with a variety of total, anterior, or posterior polypropylene kit meshes for vaginal prolapse in multiple compartments. While no difference in awareness of prolapse was able to be identified between the groups (RR 1.3, 95% CI 0.6 to 1.7) the recurrence rate on examination was higher in the native tissue repair group compared to the transvaginal polypropylene mesh group (RR 2.0, 95% CI 1.3 to 3.1). The mesh erosion rate was 35/194 (18%), and 18/194 (9%) underwent surgical correction for mesh erosion. The reoperation rate after transvaginal polypropylene mesh repair of 22/194 (11%) was higher than after the native tissue repair (7/189, 3.7%) (RR 3.1, 95% CI 1.3 to 7.3). Data from three trials compared posterior vaginal repair and transanal repair for the treatment of posterior compartment prolapse (rectocele). The posterior vaginal repair had fewer recurrent prolapse symptoms (RR 0.4, 95% CI 0.2 to 1.0) and lower recurrence on examination (RR 0.2, 95% CI 0.1 to 0.6) and on defecography (MD -1.2 cm, 95% CI -2.0 to -0.3). Sixteen trials included significant data on bladder outcomes following a variety of prolapse surgeries. Women undergoing prolapse surgery may have benefited from having continence surgery performed concomitantly, especially if they had stress urinary incontinence (RR 7.4, 95% CI 4.0 to 14) or if they were continent and had occult stress urinary incontinence demonstrated pre-operatively (RR 3.5, 95% CI 1.9 to 6.6). Following prolapse surgery, 12% of women developed de novo symptoms of bladder overactivity and 9% de novo voiding dysfunction. Authors' conclusions Sacral colpopexy has superior outcomes to a variety of vaginal procedures including sacrospinous colpopexy, uterosacral colpopexy and transvaginal mesh. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living, and increased cost of the abdominal approach. The use of mesh or graft inlays at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse on examination. Anterior vaginal polypropylene mesh also reduces awareness of prolapse, however these benefits must be weighted against increased operating time, blood loss, rate of apical or posterior compartment prolapse, de novo stress urinary incontinence, and reoperation rate for mesh exposures associated with the use of polypropylene mesh. Posterior vaginal wall repair may be better than transanal repair in the management of rectocele in terms of recurrence of prolapse. The evidence is not supportive of any grafts at the time of posterior vaginal repair. Adequately powered randomised, controlled clinical trials with blinding of assessors are urgently needed on a wide variety of issues, and they particularly need to include women's perceptions of prolapse symptoms. Following the withdrawal of some commercial transvaginal mesh kits from the market, the generalisability of the findings, especially relating to anterior compartment transvaginal mesh, should be interpreted with caution.

Background Pelvic organ prolapse is common, with some degree of prolapse seen in up to 50% of parous women in a clinic setting although many are asymptomatic. A number of symptoms may be associated with prolapse and treatments include surgery, mechanical devices and conservative therapies. A variety of mechanical devices or pessaries are described which aim to alleviate the symptoms of prolapse and avert or delay the need for surgery. Objectives To determine the effects of mechanical devices for pelvic organ prolapse. Search methods We searched the Cochrane Incontinence Group Specialised Trials Register (5 September 2005), MEDLINE (January 1966 to August Week 5 2005), PREMEDLINE (15 September 2005), EMBASE (January 1996 to Week 43 2005), CINAHL (January 1982 to February 2003), PEDro (October 2003), the UK National Research Register (Issue 3, 2003), Controlled Clinical Trials (April 2003) and ZETOC (April 2003). We searched the reference lists of relevant articles. Selection criteria Randomised and quasi-randomised controlled trials which included a mechanical device for pelvic organ prolapse in one arm of the study. Data collection and analysis No eligible, completed, published or unpublished randomised controlled studies were found, therefore no data collection or analysis was possible. Main results There was a dearth of studies on the use of mechanical devices and no published reports of randomised trials were identified. One study on pessary usage was excluded as it was not a randomised trial. Authors' conclusions Currently there is no evidence from randomised controlled trials upon which to base treatment of women with pelvic organ prolapse through the use of mechanical devices/pessaries. There is no consensus on the use of different types of device, the indications, nor the pattern of replacement and follow-up care. There is an urgent need for randomised studies to address the use of mechanical devices in comparison with no treatment, surgery and conservative measures.

The aim of this study was to assess the impact of a new guideline on the outcome of repair of obstetric anal sphincter tears by examining adherence to the guideline and the effect upon the incidence of symptoms of anal incontinence. An audit of third-degree perineal tears was conducted in 1997. A reaudit was completed in 1998 and 1999 after the introduction of a new guideline. The audits were conducted in a tertiary obstetric unit with 5000 deliveries per annum. Over the 3-year period between 1997 and 1999 124 women with a third-degree tear were identified; 14 381 women who had delivered vaginally without third-degree tears were used as controls. The main outcome measure was the number of cases with adherence to the protocol, and the number of patients with ongoing symptoms. Cases were identified from the hospital database, and case notes were reviewed to obtain clinical data. The incidence of third-degree perineal tears was 0.81% over the 3-year period. Following the introduction of a new guideline there was a significant increase in the number of repairs performed in theatre (70% vs 82% vs 97%, P